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ACTIVE NOT RECRUITING
NCT06819306
NA

The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.

Sponsor: Hedia ApS

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France. The main question to answer is: \- Does Hedia Diabetes Assistant improve glycemic control? Researchers will compare Hedia Diabetes Assistant in addition to standard treatment to standard treatment alone to see if Hedia Diabetes Assistant can improve glycemic control. Subjects will: * Use Hedia Diabetes Assistant in addition to their standard treatment or only use standard treatment for 6 months. * Visit the clinic once when they are included into the study and will otherwise be followed remotely. * Fill out questionnaires when they are included and after 6 months.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2025-03-17

Completion Date

2026-05

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DEVICE

Hedia Diabetes Assistant

Hedia Diabetes Assistant is an insulin bolus calculator app designed to calculate an insulin bolus dose recommendation for people with type 1 or type 2 diabetes on rapid-acting insulin treatment.

Locations (6)

Centre Hospitalier Universitaire d'Angers

Angers, France

Hospices Civils de Lyon

Lyon, France

Centre hospitalier universitaire de Nantes

Nantes, France

Centre hospitalier universitaire de Nîmes

Nîmes, France

Hôpital Bichat - Claude-Bernard

Paris, France

Centre hospitalier universitaire de Poitiers

Poitiers, France